Volume : 11, Issue : 12, December – 2024
Title:
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DICYCLOMINE HCL AND MEFENAMIC ACID IN DOSAGE FORM
Authors :
Chithaluri Pavan, Dr. Gadipally.sai kiran*, Dr.D. Venkata Ramana
Abstract :
A reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Dicyclomine Hydrochloride (HCL) and Mefenamic Acid in pharmaceutical dosage forms. The method was optimized for effective separation and quantification of both drugs, ensuring precision, accuracy, and reliability. The chromatographic conditions were optimized using a Waters HPLC system equipped with an auto-sampler and PDA Detector 996 model. The separation was achieved on a Hypersil C18 column (4.6×250 mm, 5 µm) with a mobile phase consisting of acetonitrile and water in a 50:50 (v/v) ratio. The flow rate was set at 1 mL/min, and the detection was performed at 235 nm. The column temperature was maintained at 35ºC, and the injection volume was 10 µL. The total run time for the analysis was 10 minutes, allowing for efficient separation and accurate estimation of both drugs within a short period. The developed method was validated according to ICH guidelines for parameters such as linearity, precision, accuracy, specificity, robustness, and limit of detection/quantification. The method showed good linearity over a concentration range, and the validation results confirmed the method’s suitability for routine quality control analysis of Dicyclomine HCL and Mefenamic Acid in their combined dosage forms.
Keywords: Dicyclomine Hydrochloride (HCL) and Mefenamic, RP-HPLC, Simultaneous Estimation, Pharmaceutical Dosage Forms, Waters HPLC.
Cite This Article:
Please cite this article in press Gadipally.Sai Kiran et al., Rp-Hplc Method Development And Validation For The Simultaneous Estimation Of Dicyclomine Hcl And Mefenamic Acid In Dosage Form.,Indo Am. J. P. Sci, 2024; 11 (12).
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